EP4088674B1 - Instrument destiné à être utilisé en chirurgie - Google Patents

Instrument destiné à être utilisé en chirurgie Download PDF

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Publication number
EP4088674B1
EP4088674B1 EP21173686.3A EP21173686A EP4088674B1 EP 4088674 B1 EP4088674 B1 EP 4088674B1 EP 21173686 A EP21173686 A EP 21173686A EP 4088674 B1 EP4088674 B1 EP 4088674B1
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EP
European Patent Office
Prior art keywords
instrument
needle
handle portion
drive shaft
hollow shaft
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP21173686.3A
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German (de)
English (en)
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EP4088674A1 (fr
Inventor
Timo Biedermann
Markku Biedermann
Achim Schünemann
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Biedermann Technologies GmbH and Co KG
Original Assignee
Biedermann Technologies GmbH and Co KG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Biedermann Technologies GmbH and Co KG filed Critical Biedermann Technologies GmbH and Co KG
Priority to EP21173686.3A priority Critical patent/EP4088674B1/fr
Priority to US17/739,703 priority patent/US20220361866A1/en
Publication of EP4088674A1 publication Critical patent/EP4088674A1/fr
Application granted granted Critical
Publication of EP4088674B1 publication Critical patent/EP4088674B1/fr
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7074—Tools specially adapted for spinal fixation operations other than for bone removal or filler handling
    • A61B17/7076—Tools specially adapted for spinal fixation operations other than for bone removal or filler handling for driving, positioning or assembling spinal clamps or bone anchors specially adapted for spinal fixation
    • A61B17/7082—Tools specially adapted for spinal fixation operations other than for bone removal or filler handling for driving, positioning or assembling spinal clamps or bone anchors specially adapted for spinal fixation for driving, i.e. rotating, screws or screw parts specially adapted for spinal fixation, e.g. for driving polyaxial or tulip-headed screws
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0469—Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0482—Needle or suture guides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/1655—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for tapping
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/1662—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body
    • A61B17/1671—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body for the spine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7074—Tools specially adapted for spinal fixation operations other than for bone removal or filler handling
    • A61B17/7092—Tools specially adapted for spinal fixation operations other than for bone removal or filler handling for checking pedicle hole has correct depth or has an intact wall
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B17/864—Pins or screws or threaded wires; nuts therefor hollow, e.g. with socket or cannulated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8897—Guide wires or guide pins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/90—Guides therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28—Surgical forceps
    • A61B17/29—Forceps for use in minimally invasive surgery
    • A61B2017/2926—Details of heads or jaws
    • A61B2017/2927—Details of heads or jaws the angular position of the head being adjustable with respect to the shaft
    • A61B2017/2929—Details of heads or jaws the angular position of the head being adjustable with respect to the shaft with a head rotatable about the longitudinal axis of the shaft
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/03—Automatic limiting or abutting means, e.g. for safety
    • A61B2090/033—Abutting means, stops, e.g. abutting on tissue or skin
    • A61B2090/034—Abutting means, stops, e.g. abutting on tissue or skin abutting on parts of the device itself

Definitions

  • the invention relates to an instrument for use in surgery in connection with a bone anchor insertion device. With the instrument, a position of a needle relative to the bone anchor can be adjusted. Further, the invention relates to a surgical instrument comprising the bone anchor insertion device and the instrument.
  • the surgical instrument may be particularly applicable in musculoskeletal surgery, and in particular, in spinal surgery.
  • a known technique involves the use of Jamshidi needles for inserting Kirschner wires (K-wires), which may be used for the placement of bone anchors such as pedicle screws.
  • K-wires Kirschner wires
  • a small incision is made in the skin of the patient.
  • a Jamshidi needle including a tiny awl is advanced through the incision to the bone.
  • a bore is prepared by hammering and turning the Jamshidi needle back and forth, and then the awl is removed.
  • a K-wire is placed into the hole and the Jamshidi needle is removed.
  • a thread cutter is guided by the K-wire to the hole, and a thread is cut with the thread cutter.
  • a bone anchor insertion device for holding and inserting a bone anchor into the bone, in particular for use with a pedicle screw is known, for example, from US 10,105,165 B2 and WO2019002992 A1 .
  • the bone anchor insertion device comprises a holding member with a seat for holding the head of the bone anchor, the holding member having two arms that are configured to encompass the head of the bone anchor, and a drive shaft for engaging the head of the bone anchor to screw the bone anchor into bone, and a displacement member acting onto the holding member such that the holding member can assume a first configuration in which the head can enter the seat and a second configuration in which the head is held in the seat and the shank of the bone anchor can be screwed into bone.
  • US 10,433,883 B2 describes surgical instruments for delivering bone anchor assemblies into bone. Use of these assemblies can eliminate one or more of the steps in a conventional bone anchor installation procedure.
  • the surgical instrument comprises a handle assembly having an elongate shaft extending distally therefrom.
  • the handle assembly can be configured to axially translate a carrier assembly that secures a stylet extending therethrough. Translation of the stylet can be made relative to a distal end of the elongate shaft.
  • An embodiment of the instrument for use in surgery that is configured to be used with a bone anchor insertion device includes a handle portion configured to be coupled to a drive shaft of the bone anchor insertion device to transmit torque to the drive shaft, a needle holder configured to receive a needle and to be translated with respect to the handle portion, an actuator rotatable with respect to the handle portion and a transmission member configured to be coupled to the needle holder and to convert a rotational movement of the actuator to a translational movement of the needle holder.
  • the transmission member comprises a first advancement structure that is configured to engage a second advancement structure provided at the handle portion for effecting the translational movement of the needle holder.
  • the instrument may be coupled to any bone insertion device, also called shank inserter, which includes a drive shaft to engage and rotate a bone anchor with a threaded shank into bone.
  • a shank inserter may have a standard coupling at the rear end of the drive shaft, for example a 1/4 inch square connection portion, that can be coupled to the instrument via a standard coupling used for 1/4 inch connection portions.
  • the instrument can form a part of a modular system and can preferably be selectively coupled to different shank inserters.
  • the instrument may be used together with an adapter carrying a navigation instrument for computer aided imaging and/or navigation.
  • a maximum length of translation of the tip of a needle which is to be used during insertion of the bone anchor is defined by the length of the handle portion which houses a hollow shaft therein in which the needle holder can travel back and forth.
  • a maximum length may be, for example, around 50 mm to 70 mm.
  • a needle of a fixed length may be used together with bone anchors having different lengths of the shank. It may be also possible to use the instrument with needles of different type and/or with needles of different length. Nevertheless the instrument is compact as a cavity formed in the handle portion that drives the drive shaft of the shank inserter is used for the path of translation of the needle holder.
  • the position of the tip of the needle in the axial direction relative to the tip of the bone anchor can be adjusted in a stepless manner. Once a position of the needle has been adjusted, this position can be maintained and the shank of the bone anchor can be screwed into the bone. Removal and/or exchange of the needle, if necessary, can be carried out in a simple and time efficient manner.
  • the instrument various techniques for anchoring the bone anchor in bone may be realized.
  • the instrument may be used in minimally invasive surgery (MIS) and preferably using bone anchors with a self cutting thread.
  • MIS minimally invasive surgery
  • a method of use comprises at least the steps of connecting the instrument to a drive shaft of an instrument for inserting a bone anchor into bone before or after connecting a cannulated bone anchor to the drive shaft, inserting a needle into the instrument and fixing the needle, translating the needle via the actuator such that a tip of the needle extends out of the tip of the bone anchor to a desired distance, inserting the needle into bone, preferably further translating the needle relative to the bone anchor to a desired depth and inserting the bone anchor along the needle by rotating the handle portion. Afterwards, the needle may be removed from the bone anchor before removing the shank inserter with the instrument or simultaneously therewith.
  • a surgical instrument in the form of a shank inserter 10 is configured to insert a bone anchor 1 into bone.
  • the bone anchor 1 usually has a threaded shank 2 with a tip 3 and may also have a head (not shown) at the end of the shank 2 opposite to the tip 3.
  • a needle 4 may be used to place the bone anchor 1 at the desired position on the bone surface and to prepare a tiny hole in the bone that defines the insertion path for the bone anchor 1.
  • the bone anchor 1 may be cannulated so that the needle 4 can extend through the bone anchor 1 from the head to the tip 3.
  • the shank 2 may have lateral openings 2a to allow bone cement or another substance to be introduced and exit therethrough.
  • the shank inserter 10 may be any of the known bone anchor insertion devices. Such a shank inserter 10 is configured to engage the bone anchor 1 usually at the head with a front end of a drive shaft 11 and to connect the bone anchor 1 to the drive shaft 11 so that torque can be transmitted via the drive shaft 11 to the shank 2 to screw the shank 2 into the bone.
  • the drive shaft 11 has a connection portion 12 at its rear end that is shaped and sized to permit quick connection to and release from other instrument parts, such as a T-handle 13 or another type of handle or adapters.
  • the connection portion 12 in the embodiment may be designed as a male connection portion with a polygon outer contour, such as a square-end.
  • connection portion 12 Adjacent to or at a small distance from the connection portion 12, there may be a groove 12a which serves for engagement by one or more holding structures or members for preventing axial movement of the drive shaft 11 when the drive shaft 11 is connected to other instrument parts. Moreover, a projection 12b may serve as an abutment in the connection to other instrument parts.
  • the drive shaft 11 is cannulated. This permits the needle 4 to extend completely through the drive shaft 11 and through the bone anchor 1.
  • shank inserter may also comprise only a drive shaft without other holding or counter holding features that engage the bone anchor
  • an instrument 100 for use with the surgical instrument can be coupled via a coupling portion 15 to the shank inserter 10, more specifically to the drive shaft 11 of the shank inserter 10.
  • the coupling portion may optionally be part of the instrument.
  • the instrument 100 includes a hollow shaft 20 that is configured to be connected via the coupling portion 15 to the drive shaft 11 of the shank inserter 10 and that is further configured to be connected to a handle portion 30.
  • the handle portion 30 can be rotated by a user whereby the torque is transmitted onto the hollow shaft 20 and as a result onto the drive shaft 11 of the shank inserter 10.
  • a fixation member 40 may be used to connect the hollow shaft 20 with the handle portion 30 in a rotational and translational fixed manner. Moreover, the hollow shaft 20 is housed at least partially in a cavity of the handle portion 30.
  • a needle holder 50 is configured to be arranged in the hollow shaft 20. The needle holder 50 can be translated within the hollow shaft 20 via an actuating mechanism to permit a tip 6 of the needle 4 to be advanced and retracted relative to the tip 3 of the shank 2 of the bone anchor 1.
  • the actuating mechanism includes an actuator 60 and a transmission member 70.
  • the actuator 60 is rotatable relative to the handle portion 30 and therefore also relative to the drive shaft 11 of the shank inserter 10.
  • the transmission member 70 is guided by the actuator 60 in such a manner that when the actuator is rotated, the transmission member 70 follows the rotational movement of the actuator and at the same time advances axially relative to the handle portion 30.
  • the transmission member 70 is connected to the needle holder 50 in such a manner that the needle holder follows the axial advancement of the transmission member 70.
  • the transmission member 70 is configured to convert a rotational movement of the actuator 60 into a translational movement of the needle holder 50. By means of this, the needle 4 can be advanced and retracted relative to the bone anchor 1 independently from a position of the bone anchor 1.
  • An axis of rotation R of the instrument 100 which is also a central longitudinal axis of the instrument parts is coaxial with the axis of rotation of the shank inserter 10 and the screw axis of the bone anchor 1.
  • the hollow shaft 20 is an elongate, substantially cylindrical part which comprises a front end 20a and a rear end 20b.
  • the front end 20a faces towards the shank inserter 10 when assembled with the shank inserter.
  • the hollow shaft 20 comprises a channel extending through the hollow shaft from the front end to the rear end such that the needle 4 can extend fully therethrough.
  • the channel has various sections described below. Adjacent to the front end 20a, there is a connection portion 21 for connecting the hollow shaft 20 to the coupling portion 15.
  • connection portion comprises at the outermost end a hollow cylindrical section 21a with an outer diameter such that the cylindrical section 21a is configured to be received in the coupling portion 15 and with an inner diameter sized to receive a portion of the drive shaft 11 behind the groove 12a ( Fig. 1 ).
  • the first step 21c may serve as an abutment for a spring of the connection portion 15.
  • the section 21b has close to the step 21c several equidistantly distributed circumferential compartments 22 for engagement members, such as balls 18, that are configured to engage the groove 12a of the drive shaft 11 and axially hold the drive shaft 11 while allowing rotation of the drive shaft.
  • a receiving section 23 for receiving the connection portion 12 of the drive shaft is formed that has an inner contour matching the outer contour of the connection section so as to provide a form-fit connection between the drive shaft 11 and the hollow shaft 20.
  • the receiving section 23 has a standard connection contour such as a quarter inch female square contour.
  • the hollow shaft 20 has a length with a slightly reduced outer diameter so that a second step 21d is formed that serves for engagement with the connection portion 15.
  • a circumferential projection 24 is provided such that between this projection 24 and a following increased diameter section a groove 24a is formed that is configured to receive a circlip or tension ring 80 ( Fig. 3 ).
  • a narrowed section 25 of the channel Adjacent to the receiving section 23 towards the rear end 20b, a narrowed section 25 of the channel may have a width that is only slightly greater than an outer diameter of the needle 4. This may provide a guidance of the needle 4 once the needle extends through the hollow shaft 20.
  • the channel then widens towards the rear end into a cylindrical needle holder receiving section 26 which serves for receiving the needle holder 50 therein.
  • the needle holder receiving section 26 has such a length that the needle holder 50 can move therein in an axial direction along a defined length.
  • At least one, preferably four axially elongate slots 27 which are closed at both ends are formed in the wall of the hollow shaft 20 equidistantly in the circumferential direction.
  • the slots 27 permit pins 73 to extend therethrough for holding the needle holder 50 as explained in detail below.
  • the position of the slots 27 in the axial direction is such that when the pins 73 abut at the front ends of the slots 27 which face towards the front end 20a of the hollow shaft, respectively, the needle holder 50 is in the foremost position ( Fig. 7 ) and when the pins abut against the opposite rear ends of the slots 27, respectively, the needle holder 50 is at the rearmost position ( Figs. 5 and 6 ).
  • an internal thread 28 is formed in the hollow shaft 20 that is configured to cooperate with an external thread 41 on a shaft of the fixation member 40 ( Figs. 3 to 7 ).
  • two projections 29 that are offset by 180° extend away from the rear end 20b.
  • the projections 29 are configured to cooperate with corresponding recesses in the handle portion 30 to provide a form-fit connection between the hollow shaft 20 and the handle portion 30. Thereby, rotation of the hollow shaft 20 relative to the handle portion 30 is prevented when the fixation member 40 is screwed into the hollow shaft. It shall be noted that other rotation preventing structures between the hollow shaft 20 and the handle portion 30 may also be envisaged.
  • the coupling portion 15 which couples the hollow shaft 20 to the drive shaft 11 will be described in greater detail.
  • the coupling portion 15 is exemplary and any outer suitable coupling can also be used.
  • the coupling portion 15 is a sleeve-like part and configured to receive a portion of the hollow shaft 20 therein. It has a front section 16 adjacent a front end 15a and a rear section 17 adjacent a rear end 15b.
  • the front section 16 is configured to receive the cylindrical section 21a of the hollow shaft 20 therein and the rear section 17 is configured to receive the receiving section 23 of the hollow shaft therein that cooperates with the connection portion 12 of the drive shaft 11.
  • the rear section 17 is flexible, for example by means of slits 17a, as best seen in Figs, 3 and 4 , that are open to the rear and 15b.
  • the slits 17a and an inner annular projection 17b at the rear end 15b enable the rear section 17 of the coupling portion 15 to be snapped over the portion 21b of the hollow shaft 20 and engage the hollow shaft at the second step 21d.
  • balls 18 are provided that extend radially to some extent through the compartments 22 in the hollow shaft 20.
  • a helical spring 19 is housed in a compartment. The helical spring 19 extends around the portion 21a of the hollow shaft 20 and abuts against the first step 21c of the hollow shaft 20.
  • the hollow shaft 20 is biased against the inner annular projection 17b so that it is firmly connected to the coupling portion.
  • the balls 18 are moved out of the groove 12a and remain in recesses of the coupling portion 15.
  • the handle portion 30 may be an elongate, substantially cylindrical part that has a front end 30a and a rear end 30b.
  • An outer surface portion 31 that extends from a position close to the rear end 30b to a distance from the front end 30a comprises a gripping structure such as, for example axial grooves. Between the outer surface portion 31 with the gripping structure and the front end, the outer diameter of the handle portion may taper to substantially match an outer diameter of a portion of the actuator 60.
  • the handle portion 30 further comprises a cylindrical bore 32 extending from the front end 30a to a distance from the rear end 30b which is provided with an internal thread 32a.
  • the pitch of the internal thread 32a corresponds to the pitch of the bone thread of the bone anchor 1.
  • the direction of the internal thread 32a is the same as the direction of the bone thread of the bone anchor 1.
  • the inner diameter of the bore 32 is such that the hollow shaft 20 and a portion of the actuator 60 can extend therein and the transmission member 70 which acts between the needle holder 50 and the handle portion 30 can engage the internal thread 32a.
  • a short cylindrical section 33 with an inner diameter that is greater than the inner diameter of the thread 32a and that may serve for receiving a portion of the actuator 60 therein.
  • Adjacent to the rear end 30b a cylindrical recess 34 is formed that is sized to receive a cylindrical head 42 of the fixation member ( Figs. 5 to 7 ).
  • a coaxial channel 35 with a reduced inner diameter compared to the diameter of the bore 32 and compared to the cylindrical section 34 is formed that has two rounded side recesses 35a offset by 180° that are configured to receive the projections 29 of the hollow shaft 20 in order to connect the hollow shaft 20 and the handle rotationally secured against each other.
  • the fixation member 40 comprises a channel 43 with an inner diameter such that the needle holder 50 can extend therein when the needle holder 50 is in the rearmost position. This allows to insert and/or remove the needle 4 through the fixation member 40.
  • the fixation member 40 has a tool engagement recess 44 in the head 42 for screwing it into the threaded section 28 of the hollow shaft 20.
  • the underside 42a of the head 42 of the fixation member is configured to abut against the bottom 34a of the recess 34 in the handle portion 30 ( Fig.6 and 7 ) to firmly connect the hollow shaft 20 and the handle portion 30 when the fixation member 40 is tightened.
  • the needle 4 includes a thin rod portion 5 with a tip 6 at the front end.
  • the tip 6 preferably is a sharp tip that is suitable for picking a hole into bone.
  • a holding portion is provided that comprises a cylindrical front portion 7, an intermediate thicker portion 8 and a head portion 9 at the rear end 4a.
  • a small shoulder 7a is formed between the rod portion 5 and the cylindrical front portion 7 .
  • two projections 8a preferably cylindrical projections, extend outward in opposite directions.
  • the projections 8a serve for mounting the needle 4 to the needle holder 50.
  • the head portion 9 comprises an engagement portion 9a for a tool at its free end.
  • the needle 4 can be pushed and rotated to mount and release it from the needle holder 50.
  • the needle can be any suitable needle, such as a Jamshidi needle or a needle having a special tip, such as a tip provided with a sensor.
  • the needle holder 50 is a substantially cylindrical part with a front end 50a and a rear end 50b. It comprises a channel extending completely through the holder from the front end 50a to the rear end 50b such that the needle 4 can be inserted from the rear end 50b with the tip 6 and can extend with the rod portion 5 all through the needle holder 50. Adjacent to the front end 50a, the channel has a front section 51 with an inner diameter large enough to guide the rod portion 5 of the needle 4 therethrough. At a distance from the front end 50a four transverse through holes 52 are formed equidistantly in the circumferential direction in the wall of the needle holder 50. The through holes 52 are configured to receive the pins 73 ( Figs.
  • a receiving section 53 for the holding portion of the needle 4 Adjacent to the rear end 50b, a receiving section 53 for the holding portion of the needle 4 is provided that has a greater inner diameter than the channel of the front portion 51. At the transition between the receiving section 53 and the front section 51 the inner diameter of the channel decreases towards the front section 51 whereby a shoulder 54 is formed that serves as an abutment for a helical spring 55 arranged in the receiving section 53.
  • the helical spring 55 biases a washer 56 against pins 57 that extend through pairs of holes 58, respectively.
  • each pin 57 extends through two holes 58 in the wall.
  • the holes 58 are offset in a circumferential and in the axial direction from the holes 52 and the inserted pins 57 extend transverse to the longitudinal direction but at a radial distance from the central longitudinal axis.
  • a distance of the pins 57 from each other is such that the rod portion 5 of the needle can extend therethrough without being hindered.
  • the pins 57 prevent falling out of the washer 56 through the rear end 50b if no needle is inside the needle holder 50.
  • two axially extending recesses 59 that are offset by 180° from each other are formed in the wall of the needle holder 50 that permit the projections 8a of the holding portion of the needle 4 to be guided therethrough when the needle 40 is inserted.
  • the recesses 50 continue into end portions 59a which extend in the circumferential direction, thus are transverse to the axial recesses 59.
  • the end portions 59a are extending circumferentially in the same direction of revolution so that, when the projections 8a reach the end portions during insertion of the needle 4, rotation in one direction moves the projections into the end portions 59a of the recesses 59, respectively, and rotation in the other direction moves them out.
  • Removal of the needle 4 functions by pushing the rear portion of the needle against the washer 56 which frees the projections 8a so that they can be moved out of the transverse end portions 59a by rotating the needle in the counter direction.
  • the end portions 59a extend in the counterclockwise direction so that pushing the needle and rotating it in the counterclockwise direction locks the needle 4 in the holder 50 while pushing it and rotating it in the clockwise direction releases the needle 4 from the holder 50. This push and turn action allows a quick and simple mounting and removal of the needle.
  • the actuator 60 is comprises a front end 60a and a rear end 60b. Adjacent to the front end 60a a substantially cylindrical gripping portion 61 is formed that has a gripping structure such as axially extending grooves at its outer surface. A passage extends completely through the gripping portion 61 and comprises a first cylindrical coaxial bore 61a adjacent the front end 60a followed by a second cylindrical coaxial bore 61b. The second cylindrical bore 61b has an inner diameter that allows to guide the hollow shaft 20 therethrough. More specifically, when the instrument is assembled, the groove 24a of the hollow shaft 20 is located just at the front end 60a of the actuator 60.
  • a rear end surface 61b of the gripping portion 61 faces towards the front end 30a of the handle portion 30 in the assembled state.
  • the posts 62 protrude the free end surface of which form the rear end 60b of the actuator 60.
  • the posts 62 have a cylindrical outer surface and a substantially flat inner surface portion 62a.
  • the gaps or slots 63 between the posts 62 form a guiding structure for the transmission member 70.
  • Adjacent to the gripping portion 61, the posts 62 have foot portions 64 which join them with the gripping portion 61.
  • An outer contour of the foot portions 64 is also cylindrical with an outer diameter slightly smaller than an outer diameter of the gripping portion 61.
  • the posts 62 protrude from the innermost side of the foot portions 64, respectively.
  • An outer diameter of the actuator 60 in the region of the posts 63 is smaller than an inner diameter of the threaded bore 32 of the handle portion 30 such that the posts 63 can extend into the bore 32 and leave sufficient space for the transmission member 70 to extend partially into that space.
  • the foot portions 64 can extend into the widened cylindrical recess 33 djacent the front end 30a of the handle portion 30 as shown in Figs. 5 and 6 .
  • the posts 62 extend into the bore 32 of the handle portion 30, as shown in Figs.
  • the rear end 60b of the actuator 60 extends beyond the internal thread 32a of the handle portion 30 towards the rear end 30b of the handle portion. This permits to fully use the thread 32a for the travel of the transmission member 70.
  • the inner diameter of the actuator 60 in the region of the posts 62 is such that the hollow shaft 20 can extend therethrough.
  • the transmission member 70 is a sleeve-like part with a front end 70a and a rear end 70b.
  • the inner passage 71 of the sleeve is sized such that the transition member 70 fits around the hollow shaft 20, preferably with only such a radial play that allows the transition member 70 to move easily along the hollow shaft 20.
  • a first ring member 72 is arranged in which the pins 73 mentioned above are mounted.
  • pins 73 are provided that extend inwards in a radial direction and are 90° offset from each other in the circumferential direction.
  • the pins 73 have such a length that they can extend through the slots 27 on the hollow shaft 20 into the transverse holes 52 of the needle holder 50 to connect the needle holder 50 to the transmission member 70 without obstructing the needle 4 when it extends through the needle holder 50.
  • the first ring member 72 is rotatable in the transmission member 70. It is secured to the transmission member 70 against escaping through the front end 70a by a step 71a in the wall of the passage 71. In addition, it is secured against escaping through the rear end 70b by a second ring member 74 that has such an inner diameter that it abuts in the mounted state against the first ring member 72.
  • the second ring member 74 is fixed to the transmission member 70 via set screws 75 engaging threaded transverse holes 76 in the transmission member 70 and corresponding threadless holes 77 in the second ring member 74.
  • the outer surface of the transmission member 70 comprises an external thread 78 that is configured to cooperate with the internal thread 32a of the handle portion 30.
  • Four axial cutouts 79 with a substantially flat bottom 79a are provided in the external surface of the transmission member 70.
  • the cutouts 79 are 90° offset from each other and have a width such that the posts 62 can extend into the cutouts 79 and are guided therein.
  • the substantially flat inner surface portion 62a of the posts 62 can slide on the flat bottom 79a of the cutouts 79.
  • the external thread 78 may have beveled portions 78a at the borders of the slots 79 to facilitate insertion of the posts 62.
  • the axial length of the transmission member 70 may be at least one, preferably at least two turns of the thread 78.
  • the parts and portions of the instrument and/or the bone anchor insertion device, the bone anchor and/or the needle may be made of any material, preferably, however, of a bio-compatible material, such as titanium or stainless steel or any other bio-compatible metal or metal alloy, or plastic material.
  • a bio-compatible material such as titanium or stainless steel or any other bio-compatible metal or metal alloy, or plastic material.
  • a bio-compatible alloy a NiTi-alloy, for example Nitinol, may be used.
  • Other materials can be Magnesium or Magnesium alloys
  • bio-compatible plastic materials for use may be for example, Polyether ether ketone (PEEK) or Poly-L-lactide acid (PLLA).
  • PEEK Polyether ether ketone
  • PLLA Poly-L-lactide acid
  • the parts can be made of the same or of different materials from one another. For the instrument a material that is easy to clean may be preferred.
  • the needle holder 50, the hollow shaft 20, the transmission member 70, the handle portion 30 and the actuator 60 are usually preassembled such that their respective front ends face in the direction of the connection portion 15.
  • the transmission member 70 is arranged around the hollow shaft so that the pins 73 which are inserted into the holes 72 extend through the slots 27 of the hollow shaft 20 into the transverse holes 52 of the needle holder 50.
  • the actuator 60 is placed with the gripping portion 61 around the hollow shaft 20 such that the posts 62 engage the cutouts 79 in the outer surface of the transmission member 70.
  • the handle portion 30 is screwed onto the transmission member 70 and the hollow shaft 20 fixed to the handle portion 30 via the fixation member 40 that is screwed from the rear end 30b of the handle 30 into the thread 28 of the hollow shaft 20.
  • the circlip 80 is placed into the groove 24a and forms an abutment for the front end 60a of the actuator 60. Tightening the fixation member 40 firmly fixes the hollow shaft 20 to the handle 30 so that rotation of the handle 30 also rotates the hollow shaft 20.
  • the actuator is rotatable with respect to the hollow shaft 20 and with respect to the handle portion 30.
  • the rotational movement of the posts 62 forces the transmission member 70 to travel in axial direction via the engagement of the thread 78 of the transmission member 70 and the thread 32a of the handle portion 30. Since the transmission member 70 is connected via the pins 73 to the needle holder 50, the needle holder 50 will travel together with the transmission member 70.
  • the needle holder 50 When the pins 73 abut against the front end of the slots 27, the needle holder 50 is in its foremost or advanced position as shown in Fig. 7 , and the tip 6 of an inserted needle 4 can assume its greatest distance from the tip 3 of the bone anchor.
  • the pins 73 abut against the rearward end of the slots 27 in the hollow shaft 20 as depicted in Figs. 5 and 6 , the tip 6 of an inserted needle is in its rearmost or retracted position.
  • the coupling portion 15 is mounted to the connection portion 21 of the hollow shaft in that the rear section 17 of the coupling portion 15 is snapped over the connection portion 21 so that the second step 21d is engaged by the inner annular rim 17b of the connection portion 15 as shown in Figs. 5 to 7 .
  • the instrument 100 preassembled in this manner can be connected to a shank inserter 10.
  • the connection portion 12 of the drive shaft 11 is inserted into the connection portion 21 of the hollow shaft so that it is received in the receiving section 23 so that the form-fit engagement allows to transmit torque to the drive shaft 11.
  • the shank inserter may be already connected to a bone anchor 1 to be inserted into bone or the bone anchor 1 can be fixed to the instrument when the shank inserter has been connected to the instrument 100.
  • the needle 4 can be inserted.
  • the needle holder 50 is moved by rotating the actuator in the counter-clockwise direction until the needle holder 50 is in the rearmost position as shown in Figs. 5 and 6 .
  • the needle 4 is inserted through the fixation member 40 and guided with the tip 6 and the rod portion 5 fully through instrument 100 and the shank inserter until the tip 6 protrudes out of the shank 2 of the bone anchor 1.
  • the needle 4 is fixed to the needle holder 50 by a push and turn action to move the projections 8a into the end portions 59a of the axial recesses 59. Removal of the needle 4 can be accomplished by pushing it and rotating it in the other direction.
  • the instrument 100 is coupled to the shank inserter 10.
  • the shank inserter 10 may be already attached to a bone anchor 1.
  • the needle 4 is inserted and locked in the needle holder.
  • the needle 4 is advanced to such an extent that the tip 6 of the needle 4 projects to a desired distance out of the tip 3 of the bone anchor 1.
  • the position of the needle 4 can be adjusted in a stepless manner.
  • the surgical instrument prepared by this is ready to insert the bone anchor 1 into bone, in the example in the pedicle of a vertebra 500.
  • the bone anchor is placed onto the bone surface and the tip 6 of the needle 4 is hit into the bone until the needle has penetrated the cortical bone.
  • the handle portion 30 is held stationary and the actuator 60 is rotated by gripping and rotating the gripping portion 61 in the clockwise direction. Thereby, the needle 4 penetrates deeper into the bone.
  • the gripping portion 61 of the actuator 60 is held stationary and the handle portion 30 is rotated in the clockwise direction to screw the bone anchor 1 over the needle 4 into the bone.
  • the bone anchor 1 is a self-tapping bone anchor that is configured to cut the thread into the bone by itself during rotation.
  • shank inserter 10 can be decoupled from the bone anchor 1 together with the instrument 100 still attached to the shank inserter and the needle 4 still extending through the entire device.
  • the needle 4 is removed first and the shank inserter 10 is released from the bone anchor thereafter.
  • the needle can travel covers about a length of the shank of a usual bone anchor or more, the instrument 100 and the same needle 4 can be used in connection with different bone anchors having different lengths.
  • a second embodiment of the surgical instrument is shown. Identical or highly similar parts and portions are indicated with the same reference numerals and the description thereof is non-repeated.
  • the shank inserter 10 and the instrument 100 are identical to the previous embodiment. However, between the shank inserter 10 and the instrument 100 an adapter 90 is mounted that has a rear end that is coupled to the hollow shaft 20 in the same manner as the drive shaft 11 of the previous embodiment.
  • the adapter 90 has a front connection portion that is connected to the shank inserter 10.
  • the hollow shaft 20 of the instrument 100 is coupled to an inner shaft (not shown) of the adapter member 90 which is also coupled to the drive shaft of the shank inserter 10.
  • a secondary instrument 101 such as a navigation array that includes transmitters or receivers for electromagnetic radiation can be mounted on the adapter member 90 via a mounting sleeve 91.
  • the mounting sleeve 91 may be, for example, rotatable around the shaft of the adapter member 90.
  • the instrument can also be used for inserting a syringe for injecting bone cement or other substances after or instead of a needle as shown in the embodiment.
  • a syringe for injecting bone cement or other substances after or instead of a needle as shown in the embodiment.
  • any suitable actuating mechanism that can convert a rotational motion of an actuator into a translational motion of the needle holder can be used.
  • the instrument can also be used in connection with a drill instead of a shank inserter or with other suitable surgical instruments.
  • the instrument can also be used without a needle or with needles of different type and length.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Neurology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Dentistry (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Rheumatology (AREA)
  • Surgical Instruments (AREA)

Claims (15)

  1. Un instrument destiné à être utilisé en chirurgie en relation avec un dispositif d'insertion d'ancrage osseux dans lequel le dispositif d'insertion d'ancrage osseux (10) comprend un arbre d'entraînement (11) étant connectable à une tige (2) d'un ancrage osseux (1), l'arbre d'entraînement (11) comprenant un canal pour recevoir une aiguille (4) à travers celui-ci ; l'instrument comprenant
    une partie de poignée (30) configurée pour être couplée à l'arbre d'entraînement (11) pour transmettre un couple à l'arbre d'entraînement (11) ;
    un porte-aiguille (50) configuré pour recevoir une aiguille (4) et pour être translaté par rapport à l'arbre d'entraînement (11);
    un actionneur (60) pouvant tourner par rapport à la partie de poignée (30) ; et
    un élément de transmission (70) configuré pour être couplé au porte-aiguille (50) et pour convertir un mouvement de rotation de l'actionneur (60) en un mouvement de translation du porte-aiguille (50) pour faire avancer et rétracter l'aiguille (4) ;
    dans lequel l'élément de transmission (70) comprend une première structure d'avancement (78) qui est configurée pour venir en prise avec une deuxième structure d'avancement (32a) prévue au niveau de la partie de poignée (30) pour effectuer le mouvement de translation du porte-aiguille (50).
  2. L'instrument selon la revendication 1, dans lequel la partie de poignée (50) comprend un passage allongé (32) ayant une surface interne et dans lequel la première structure d'avancement (78) est prévue sur une surface externe de l'élément de transmission (70) et la deuxième structure d'avancement (32a) est prévue sur la surface interne du passage (32) de la partie de poignée (30).
  3. L'instrument selon la revendication 1 ou 2, dans lequel la première structure d'avancement (78) et la deuxième structure d'avancement (32a) est configurée de telle sorte que la distance par révolution sur laquelle l'élément de transmission (70) se déplace axialement correspond à la distance sur laquelle une tige (2) est avancée par révolution de la partie de poignée (3).
  4. L'instrument selon l'une des revendications 1 à 3, dans lequel la première structure d'avancement (78) et la deuxième structure d'avancement (32a) sont des filetages.
  5. L'instrument selon l'une des revendications 2 à 4, dans lequel un arbre creux (20) qui est connectable à l'arbre d'entraînement (11) et à la partie de poignée (30) est agencé dans le passage (32) de la partie de poignée (30) et dans lequel le porte-aiguille (50) est agencé dans l'arbre creux (20).
  6. L'instrument selon la revendication 5, dans lequel l'arbre creux (20) comprend une partie d'extrémité (21) qui est configurée pour être connectable de manière amovible à une partie d'extrémité (12) de l'arbre d'entraînement, de préférence via un couplage standard, tel qu'un couplage quart de pouce.
  7. L'instrument selon la revendication 5 ou 6, dans lequel un élément de fixation (40) est prévu qui est configuré pour connecter de manière fixe l'arbre creux (20) à la partie de poignée (30) à une extrémité de l'arbre creux (20) orientée à l'opposé de l'arbre d'entraînement (11).
  8. L'instrument selon la revendication 7, dans lequel l'élément de fixation (40) comprend un passage (43) qui est configuré pour permettre à au moins une partie de l'aiguille (4) de s'étendre à travers celui-ci.
  9. L'instrument selon l'une des revendications 1 à 8, dans lequel le porte-aiguille (50) est configuré pour recevoir de manière amovible une aiguille (4) dans celui-ci, de préférence dans lequel l'aiguille (4) est amovible ou interchangeable sans démonter l'instrument.
  10. L'instrument selon la revendication 9, dans lequel l'aiguille (4) est montable sur et amovible du porte-aiguille (50) par une action de poussée et de rotation.
  11. L'instrument selon l'une des revendications 5 à 10, dans lequel l'élément de transmission (70) est une partie en forme de manchon qui s'étend autour de l'arbre creux (20).
  12. L'instrument selon la revendication 11, dans lequel l'élément de transmission (70) comprend au moins un élément de mise en prise (73) qui vient en prise avec le porte-aiguille (50) et dans lequel l'élément de mise en prise (73) est guidé dans un évidement (27) de l'arbre creux, de préférence dans lequel une longueur axiale de l'évidement (27) définit une longueur du mouvement de translation du porte-aiguille (50).
  13. L'instrument selon l'une des revendications 2 à 12, dans lequel l'actionneur (60) comprend une partie de préhension en forme de manchon (61) agencée autour d'un axe de rotation (R) de la partie de poignée (30) et une structure de guidage (62, 63) s'étendant dans le passage (32) de la partie de poignée (30) pour faire avancer l'élément de transmission (70) lorsque l'actionneur (60) est tourné.
  14. L'instrument selon la revendication 13, dans lequel la structure de guidage comprend au moins deux éléments d'extension (52) s'étendant dans la direction axiale et ayant entre eux un espace (63) qui est dimensionné de manière à permettre à la deuxième structure d'avancement (78) de l'élément de transmission (70) de s'étendre à travers l'espace (63) pour venir en prise avec la première structure d'avancement (32a) au niveau de la partie de poignée (30).
  15. Un instrument chirurgical comprenant l'instrument selon l'une des revendications 1 à 14 et un dispositif d'insertion d'ancrage osseux (10) comprenant un arbre d'entraînement (11) configuré pour venir en prise avec une tige (2) et/ou une tête d'un ancrage osseux (1), de préférence dans lequel l'arbre d'entraînement (11) est canulé.
EP21173686.3A 2021-05-12 2021-05-12 Instrument destiné à être utilisé en chirurgie Active EP4088674B1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
EP21173686.3A EP4088674B1 (fr) 2021-05-12 2021-05-12 Instrument destiné à être utilisé en chirurgie
US17/739,703 US20220361866A1 (en) 2021-05-12 2022-05-09 Instrument for use in surgery

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP21173686.3A EP4088674B1 (fr) 2021-05-12 2021-05-12 Instrument destiné à être utilisé en chirurgie

Publications (2)

Publication Number Publication Date
EP4088674A1 EP4088674A1 (fr) 2022-11-16
EP4088674B1 true EP4088674B1 (fr) 2023-11-29

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US (1) US20220361866A1 (fr)
EP (1) EP4088674B1 (fr)

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9254160B2 (en) * 2013-03-14 2016-02-09 Aesculap Implant Systems, Llc Driver assembly with guidewire control mechanism
EP3269321B1 (fr) 2014-03-14 2020-07-01 Biedermann Technologies GmbH & Co. KG Instrument pour tenir et insérer un ancrage osseux
US10433883B2 (en) 2017-06-27 2019-10-08 Medos International Sarl Spinal screw insertion devices and methods
US10779872B2 (en) * 2017-11-02 2020-09-22 Medos International Sarl Bone anchor insertion instruments and methods

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EP4088674A1 (fr) 2022-11-16
US20220361866A1 (en) 2022-11-17

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